Qiagen Hybrid Capture System Microplate Heater 1 User manual

Sample to Insight
April 2023
Hybrid Capture®System
Microplate Heater 1 User Manual
6000
-1110U (120 V)
6000
-1240U (230 V)
QIAGEN
19300 Germantown Road Germantown, MD 20874 USA
QIAGEN GmbH
QIAGEN Strasse 1 40724 Hilden GERMANY
R1
1128780

Hybrid Capture System Microplate Heater 1 User Manual 04/2023
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Contents
1Introduction .................................................................................................................................................. 4
About this user manual......................................................................................................................... 4
General information............................................................................................................................. 4
Technical assistance..................................................................................................................... 4
Policy statement........................................................................................................................... 4
Version management ................................................................................................................... 5
Intended use ....................................................................................................................................... 5
Materials required ............................................................................................................................... 5
Materials required but not provided....................................................................................................... 5
2Safety Information ......................................................................................................................................... 6
Proper use .......................................................................................................................................... 6
Electrical safety ................................................................................................................................... 7
Environment........................................................................................................................................ 7
Biological safety.................................................................................................................................. 8
Waste disposal ................................................................................................................................... 8
Symbols ............................................................................................................................................. 9
3General Description .................................................................................................................................... 11
Control elements................................................................................................................................ 11
Heater control panel .......................................................................................................................... 12
Heater plates ............................................................................................................................ 12
Heater control panel .................................................................................................................. 13
RTD port ................................................................................................................................... 13
4Installation Procedures ................................................................................................................................. 14
Unpacking........................................................................................................................................ 14
Getting started .................................................................................................................................. 14
5General Operation...................................................................................................................................... 15
Setting the temperature....................................................................................................................... 15
Inserting a plate ................................................................................................................................ 15
Managing the temperature ................................................................................................................. 15
Viewing the set-point.................................................................................................................. 15
Changing the set-point ............................................................................................................... 15

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Timer function – Accumulated time....................................................................................................... 16
Timer function – Remaining time .......................................................................................................... 16
Beeper preference ............................................................................................................................. 16
Temperature calibration ..................................................................................................................... 16
Calibration tool ......................................................................................................................... 17
6Maintenance .............................................................................................................................................. 18
Monthly cleaning and decontamination................................................................................................ 18
Replacing a fuse................................................................................................................................ 19
Servicing .......................................................................................................................................... 19
7Troubleshooting .......................................................................................................................................... 20
8Technical Data............................................................................................................................................ 21
Operating conditions ......................................................................................................................... 21
Transport conditions........................................................................................................................... 22
Storage conditions............................................................................................................................. 22
Appendices ..........................................................................................................................................................23
Appendix A – Waste Electrical and Electronic Equipment (WEEE)..................................................................... 23
Appendix B – Warranty............................................................................................................................... 23
Appendix C – FCC Declaration .................................................................................................................... 24
Ordering Information ............................................................................................................................................. 25
Document Revision History...................................................................................................................................... 26

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1Introduction
The Hybrid Capture System (HCS) Microplate Heater 1 has been designed specifically for use with the digene
®HC2 DNA tests.
Read this user manual before operating the HCS Microplate Heater 1.
About this user manual
This user manual provides information about the HCS Microplate Heater in the following sections:
Introduction
Safety Information
General Description
Installation
General Operation
Maintenance
Troubleshooting
Technical Data
Appendices
Ordering Information
Document Revision History
The appendices contain the following information:
Appendix A – Waste Electrical and Electronic Equipment (WEEE)
Appendix B – Warranty
Appendix C – FCC Declaration
General information
Technical assistance
For technical assistance and more information, please see our Technical Support Center at www.qiagen.com/TechSupportCenter
or contact QIAGEN®Technical Services or a local distributor.
Policy statement
It is the policy of QIAGEN to improve products as new techniques and components become available. QIAGEN reserves the
right to change specifications at any time. In an effort to produce useful and appropriate documentation, we appreciate your
comments on this user manual. Please contact QIAGEN Technical Services.

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Version management
This document is Hybrid Capture System Microplate Heater 1 User Manual . See the front cover of this user manual for document
number and revision information.
Intended use
The HCS Microplate Heater 1 is an electronically controlled heating unit and is intended for use only in conjunction with digene
Hybrid Capture 2 (HC2) DNA tests as described in the respective
digene HC2 DNA test instructions for use. The HCS Microplate
Heater 1 is intended for professional use.
Materials required
HCS Microplate Heater 1
T-type thermocouple
Aluminum heat block
Power cord
Materials required but not provided
Digital thermometer (compatible with T-type thermocouple connector)

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2Safety Information
This manual contains information about warnings and cautions that must be followed by the user to ensure safe operation of the
HCS Microplate Heater 1 and to maintain the instrument in a safe condition.
WARNING
The term WARNING is used to inform you about situations that could result in personal injury to you or other
persons.
Details about these circumstances are provided to avoid personal injury to you or other persons.
CAUTION
The term CAUTION is used to inform you about situations that could result in damage to the instrument or other
equipment.
Details about these circumstances are provided to avoid damage to the instrument or other equipment.
Please be aware that you may be required to consult your local regulations for reporting serious incidents that have occurred in
relation to the device to the manufacturer and/or its authorized representative and the regulatory authority in which the user and/or
the patient is established.
Before using the instrument, it is essential to read this manual carefully and to pay particular attention to any details it contains
concerning hazards that may arise from the use of the instrument.
The details given in this manual are intended to supplement, not supersede, the normal safety requirements prevailing in the
user’s country.
Proper use
WARNING/
CAUTION
Risk of personal injury and material damage
Improper use of the HCS Microplate Heater 1 may cause personal injuries to the user or damage to the
instrument.
The HCS Microplate Heater 1 must only be operated by qualified personnel who have been appropriately
trained.

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Electrical safety
Only operate the HCS Microplate Heater 1 with the power cord provided with the instrument. For satisfactory and safe operation
of the HCS Microplate Heater 1, it is essential that the line power cord is connected to true electrical earth (ground).
WARNING Electrical hazard
The HCS Microplate Heater 1 must be grounded for protection against electrical shock.
Do not use an adapter to a 2-terminal outlet because this does not provide positive ground protection.
WARNING
Electrical fire hazard
Before turning on the instrument, make sure that the fuses are properly installed. The use of improper fuses can
damage the wiring system and cause a fire.
To reduce the chance of electrical shock, do not remove covers that require tool access. No user-serviceable parts are inside.
The 3-prong power cord and receptacle contain the grounding connector. Grounding circuit continuity is vital for safe operation
of equipment. Never operate equipment with the grounding connector disconnected. To avoid electrical shock, disconnect the
power cord before servicing.
To protect against fire hazard, replace only with same-rated fuses as described in “Replacing a fuse” on page 19.
WARNING
Risk of personal injury
Use care when using the instrument to avoid being burned by hot components.
Environment
CAUTION Risk of personal injury and material damage
Do not use in the presence of flammable or combustible materials or explosive gases. Do not use in the presence
of pressurized or sealed containers. Fire or explosion may result causing death or severe injury.
CAUTION
Risk of material damage
Do not operate in a cold room or refrigerated area.
CAUTION Risk of improper operation

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Evaluate the electromagnetic environment prior to operation of the device. Do not use this device in close
proximity to sources of strong electromagnetic radiation (e.g., unshielded intentional RF sources), as these can
interfere with the proper operation.
Biological safety
WARNING Hazardous substances
The products used with this instrument may contain hazardous substances.
When working with chemicals, always wear a suitable lab coat, disposable gloves, and protective goggles. For
more information, please consult the appropriate safety data sheets (SDSs). These are available online in PDF
format at www.qiagen.com/safety where you can find, view, and print the SDS for each QIAGEN kit and kit
component. For further information see the instructions for use that come with the kit.
WARNING/
CAUTION
Risk of personal injury and material damage
Consider any laboratory equipment used for research or clinical analysis a potential biohazard that requires
decontamination before reuse.
WARNING
Risk of personal injury
Sodium hypochlorite solution is caustic; wear rubber gloves and eye protection when handling it.
To dispose of the HCS Microplate Heater 1, follow all national, state, and local health and safety regulations and laws for
disposing of laboratory waste. For disposal of Waste Electrical and Electronic Equipment (WEEE compliance), see “Appendix A
– Waste Electrical and Electronic Equipment (WEEE),” page 23.
Waste disposal
Waste may contain certain hazardous chemicals or contagious/biohazardous materials and must be collected and disposed of
properly in accordance with all national, state, and local health and safety regulations and laws.

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Symbols
The following symbols may be found on the instrument, in this user manual, or on labels associated with the instrument.
Symbol
Location
Description
On the instrument General warning sign
On the instrument Warning, hot surface
On the instrument Warning, biological hazard
Type plate on the back of the instrument and
instrument box label
RCM mark for Australia
Type plate on the instrument, instrument box label,
and the front cover of this user manual
CE mark for Europe
Type plate on the instrument, instrument box label,
and the front cover of this user manual
In vitro diagnostic medical device
Type plate on the back of the instrument and
instrument box label
The instrument complies with applicable standards for
electrical safety of laboratory equipment
Type plate on the back of the instrument and
instrument box label
RoHS mark for China (the restriction of the use of
certain hazardous substances in electrical and
electronic equipment)

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Symbol
Location
Description
Type plate on the back of the instrument and
instrument box label
Waste Electrical and Electronic Equipment (WEEE)
Type plate on the back of the instrument and
instrument box label
Serial number
Type plate on the instrument, instrument box label,
and the front cover of this user manual
Manufacturer
Type plate on the instrument, instrument box label,
and the front cover of this user manual
Catalog number
In this user manual, type plate on the back of the
instrument and instrument box label
Consult instructions for use
Type plate on the back of the instrument and
instrument box label
Global Trade Item Number
Instrument box label Fragile, handle with care
Front cover of this user manual and instrument box
label
Authorized representative in the European Community

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3General Description
The HCS Microplate Heater 1 is an electronically controlled heating unit composed of a heater base with dual (upper and
lower) heating elements with an incorporated resistance temperature detector block temperature sensor and a high-grade
aluminum heater block.
The heater block is designed to accept 96-well microplates used in conjunction with
digene HC2 DNA tests. The dual heating
elements and the heat capacity of the block provide the thermal characteristics necessary for incubation/hybridization steps of
the
digene HC2 DNA tests. These characteristics are controlled and maintained by an integrated electronic device that also
provides a digital light emitting diode display.
Control elements
All of the operating controls for the HCS Microplate Heater 1 are located on the top front. The following figures show the major
components of the instrument.
Heater cover Heater control panel
Heater cover handle
Power inlet RTD Port
Fuse drawer
1
3
2
1
2
3
1
2
3
1
2
3

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Heater control panel
Power/Standby button:Turns the unit on or places it into standby mode.
Standby indicator light: Illuminates when unit is in standby mode.
Timer up/down arrows:Increases/decreases time set-point.
Timer on/off button: Turns the timer function on or off.
Time display:Displays accumulated time or how much time is remaining.
Temperature up/down arrows:Controls temperature set-point.
Heater indicator light:Illuminates when the heating function is turned on.
Heater on/off button:Turns the heating function on or off.
Temperature display:Displays the actual/set-point temperatures.
Caution hot top indicator light:Illuminates when the plate temperature is above 40°C.
Probe indicator light:Illuminates if an external RTD probe is plugged in.
Set-point indicator light:Illuminates when the set-point temperature is displayed.
Plate indicator light:Illuminates when the heat plate temperature is displayed.
Actual indicator light:Illuminates when the actual heat plate/RTD probe temperature is displayed.
Heater plates
The aluminum heater block of the HCS Microplate Heater 1 is heated by 2 heater plates. One heater plate heats the bottom of
the block, and the other heater plate is in the cover. The block temperature sensor probe uses a platinum resistance temperature
detector. A microprocessor-based controller simultaneously turns each of the plate heaters on and off, proportionally, to maintain
the desired temperature set-point. The parameters of the temperature controller are optimized for this specific application.
The HCS Microplate Heater 1 has an upper temperature limit of 120°C.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
1
4
5
8
3
7
13
6
9
10
11
12
14
2

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Heater control panel
The heater control panel has a user-friendly interface. When power/standby button on the HCS Microplate Heater 1 is turned
on, the temperature display will cycle between the actual plate temperature and the set-point. To begin heating, press the heater
on/off button.
RTD port
Note: The RTD port is not used for digene HC2 DNA tests.
The HCS Microplate Heater 1 has an internal RTD on the heat plate to detect and control the temperature of the heat block.
Optionally, an external RTD plugged into the RTD port can be used to detect and control the heat block’s temperature. With the
RTD probe plugged into the back of the unit, place the thermometer portion in the thermometer well of the heat block. The
probe indicator light will be illuminated. The RTD probe will now control the heat block temperature and not the internal RTD
on the heat plate.

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4Installation Procedures
Unpacking
Before using the HCS Microplate Heater 1 for the first time, examine the exterior carton and the equipment itself for damages.
In the event of shipping damage, call your local QIAGEN representative or QIAGEN Technical Services.
Carefully unpack the unit and verify the contents of the package. The package should contain the following:
1 HCS Microplate Heater 1
1 Power cord
1 T-type thermocouple (used for calibration)
1 Aluminum heat block
If any of these items are missing, please contact your local QIAGEN representative or QIAGEN Technical Services immediately.
Save the original packaging until the unit has been operated successfully.
Note: For Technical Data, see page 21.
Getting started
Follow procedure for startup.
1. Verify the unit is rated for the proper voltage by checking the panel on the back of the unit.
2. Place the HCS Microplate Heater 1 on a non-flammable flat surface and in a location where surrounding objects will not be
affected by the heat it generates.
3. Do not block the circulation of air to the vents located on the sides of the unit.
A minimum of 6 inches (15 cm) of clearance on all sides of the unit is needed for proper ventilation.
4. Allow sufficient access to the power cord after installation to ensure it can be disconnected.
5. Insert the aluminum heat block into the HCS Microplate Heater 1. Orient the heat aluminum block so that the thermometer
well is toward the front of the instrument.
6. Before plugging the unit into any power source, be certain that the outlet is the correct voltage and is properly grounded.
7. Do not plug the unit into an electrical outlet until all packing materials have been removed from the HCS Microplate
Heater 1.
8. Plug the cord into the power inlet module located at the rear of the HCS Microplate Heater 1 and then into a grounded
outlet that meets the electrical specifications on the unit’s equipment type plate.

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5General Operation
Setting the temperature
Note: The HCS Microplate Heater 1 must equilibrate to temperature for 60 minutes from a cold start before being used in a test
procedure.
1. Press the main power/standby button to turn the unit on.
2. Press the heater on/off button to begin heating. The heater indicator light will illuminate when the heating function is turned
on.
3. Check the temperature set-point by observing the temperature display when the set-point indicator light is illuminated.
4. If necessary, change the set-point by pressing the temperature up/down arrows (or ) to adjust the temperature set-point of
the HCS Microplate Heater 1.
5. Allow 60 minutes for the HCS Microplate Heater 1 to equilibrate to the set temperature.
Inserting a plate
1. Using the heater cover handle, open the cover.
2. Insert the microplate into the block.
3. Close the cover as promptly as possible.
Managing the temperature
Viewing the set-point
The temperature display will cycle approximately every 3 seconds between the set-point and the actual plate temperature. The
set-point is displayed when the set-point indicator light illuminates.
Changing the set-point
1. While the current set-point temperature is showing on the temperature display, press one of the temperature up/down
buttons ( or ) to change the set-point.
Note: The longer the temperature adjustment buttons (or ) are pressed, the faster the set-point display will change.
2. Once the desired set-point is shown on the temperature display, the set-point has been changed. Three audible beeps will
indicate the set-point has been reached.

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Timer function – Accumulated time
1. By default, the timer will begin at zero (0:00) minutes. Press the timer on/off button to begin timing.
2. Press the timer on/off button to stop timing. Press the timer on/off button again to resume timing.
3. To reset the time to zero (0:00) minutes, make sure the timing is stopped, and press and hold the timer on/off button for
3 seconds. Alternately, while of the timing is stopped, simultaneously press the timer up and down arrows to reset the time
to zero (0:00) minutes.
Timer function – Remaining time
1. Press the timer up/down arrows until you reach the desired time remaining.
2. Press the timer on/off button to start the countdown.
3. Important: If the timer is used in conjunction with the heating function and the time display reaches zero (0:00), both the
time and heating functions will shut off automatically. Four audible beeps will indicate the countdown function is complete,
and the time display will default back to the set time.
4. To repeat for the same time, press the timer on/off button again.
5. To interrupt an automatic timing cycle before it is completed, press the on/off button to the right of the time display. The
time display will flash until you resume the time function by pressing the on/off button again. This interruption will not stop
the heating function; the heating function will stop only when the timer reaches zero (0:00).
Beeper preference
1. To silence beeper operation (except for error codes): with the unit in standby mode, press and hold the time on/off button
and press the power/standby button.
2. To restore normal beeper operation: remove AC power to unit for 10 seconds and then restore. Alternately, you may have
to turn the unit on and simultaneously press and hold the power/standby button and press and hold the time on/off button.
Temperature calibration
QIAGEN recommends that users verify the temperature of the HCS Microplate Heater 1 every 6 months.
Use only the T-type thermocouple included with the HCS Microplate Heater 1 when performing temperature calibration. The T-
type thermocouple is most accurate within the temperature range utilized by the HCS Microplate Heater 1. Not using a T-type
probe, such as a K-type probe, will produce a mismatch bias that is accentuated at higher temperatures.

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Calibration tool
The following equipment or equivalent is required for calibration; this equipment is not supplied with the HCS Microplate Heater 1:
Digital thermometer compatible with T-type thermocouple connector; accuracy of ±0.1%, resolution of 0.1°C. (TEGAM,
Model 819 or equivalent; www.tegam.com).
Calibrate thermometers and thermocouples together as a pair at least every 12 months. Use a standardized thermometer (such
as one traceable to the National Institute of Standards and Technology or the National Physical Laboratory) to conduct this
calibration.
Calibration procedure
1. Attach the T-type thermocouple included with the HCS Microplate Heater 1 to a calibrated digital thermometer. Set the
digital thermometer mode to T-type.
2. Place the thermometer portion of the thermocouple in the thermometer well of the heat block.
3. Route the thermocouple wire under the heater cover so that the seal between the heater cover and the heater body is
minimally disrupted.
4. Power on the HCS Microplate Heater 1, adjust the set-point to 65°C, turn the heating function on, and allow the
temperature to equilibrate.
Note: The HCS Microplate Heater 1 requires 60 minutes to equilibrate to 65°C from a cold start.
5. After a minimum of one hour, determine the measured temperature.
If the measured temperature varies less than one degree from the displayed temperature, a temperature calibration value
change is not needed.
If the measured temperature varies one degree or more from the displayed set temperature, adjust the temperature
calibration value.
Adjusting the calibration value
1. Press and hold the power/standby button, then press the temperature down button once to clear the previous calibration
value. The unit will beep 2 times, confirming that the previous calibration value has been cleared.
2. Allow the HCS Microplate Heater 1 to stabilize for 1 hour.
3. Press and hold the power/standby button, then press the temperature up button once. The unit will beep 2 times, confirming
calibration mode. The display will now be flashing.
4. Press the temperature up/down arrows until the display matches the temperature probe/thermometer.
5. Press power/standby button to exit calibration mode and return to normal heating.
6. Repeat the temperature calibration.

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6Maintenance
If you have a problem with maintenance of the HCS Microplate Heater 1, contact QIAGEN Technical Services. QIAGEN charges
for repairs that are required due to incorrect maintenance.
Monthly cleaning and decontamination
WARNING/
CAUTION
Risk of personal injury and material damage
Consider any laboratory equipment used for research or clinical analysis a potential biohazard that requires
decontamination before reuse.
Before using any cleaning or decontamination method, except those recommended in this user manual, check with QIAGEN
Technical Services to make sure that the proposed method will not damage the equipment.
The user is responsible for decontaminating the instrument if hazardous materials are spilled on or inside the aluminum block
well.
Wear powder-free gloves when handling potentially contaminated equipment.
Wipe down exposed surfaces of the HCS Microplate Heater 1 using a cleaning pad wetted with a solution of 0.5% sodium
hypochlorite (NaOCl or bleach).
Industrial bleach contains 10% NaOCl; household bleach contains 5% NaOCl. When using industrial bleach, prepare a
1:20 mixture of bleach to water. When using household bleach, prepare a 1:10 mixture of bleach to water.
Clean the outside of the unit with a mild detergent.
WARNING
Risk of personal injury
Sodium hypochlorite solution is caustic; wear rubber gloves and eye protection when handling it.

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Replacing a fuse
Only use fuses of the same type and rating for the voltage in your location.
Voltage
HCS Microplate Heater 1
catalog number Amp Type
120 V 6000-1110U 5 AMP 250 volt 5 x 20 mm
fast acting UL-listed fuse
230 V 6000-1240U 5 AMP 250 volt 5 x 20 mm
fast acting UL-listed fuse
The following graphic shows the location to pry open the fuse drawer.
Fuse drawer
1. Remove the power cord from the rear of the HCS Microplate Heater 1.
2. Pry open the fuse drawer with a small flathead screwdriver (see graphic, above).
3. Gently remove the fuse.
4. Replace the fuse.
5. Slide the fuse drawer in until the drawer snaps in place.
6. Connect the power cord.
Servicing
Maintain your instrument in good working order. In the event that the instrument is subjected to adverse conditions, such as a
fire, flood, or earthquake, schedule a service inspection of the instrument to ensure safe operation. Do not attempt to repair the
instrument. Removing the case will nullify the warranty. In the event that the product is inoperable, please contact QIAGEN
Technical Services and provide full failure details. When making your call, please ensure that you have the serial number of the
instrument.
Do not ship the instrument back for repair until advised to do so by QIAGEN Technical Services.
In the event that you are requested to return the instrument or any part thereof, it is your legal requirement to ensure that the unit
is fully decontaminated. QIAGEN Technical Services may request a certificate is included with the instrument to verify the
decontamination. Failure to do this may result in the refusal to repair the unit. Contact QIAGEN Technical Services for a Return
Goods Authorization (RGA) number. Mark this number on the outside of the shipping box.
1
1

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7Troubleshooting
Refer to this section for error handling and troubleshooting. If the recommended steps do not resolve the problem, contact
QIAGEN Technical Services for assistance.
Possible problem or cause Corrective action
Blank display
a) The power cord is not plugged
in properly
Make sure that the power cord is plugged into a known, grounded, working power source.
b) A fuse may be missing or blown Replace the fuse. See “Replacing a fuse”, page 19.
Error code is displayed
Notes: Pressing the standby button will clear error codes.
Errors will cause heating function to cease. Timing functions will be unaffected.
a) E1: Faulty temperature sensor This error cannot be fixed by the end user. Contact QIAGEN Technical Services for assistance.
b) E2: Internal RTD failure or
heating element failure.
This error cannot be fixed by the end user. Contact QIAGEN Technical Services for assistance.
c) E3: Unit cannot reach set-point
or Probe not in thermometer well
Contact QIAGEN Technical Services for assistance.